This invention relates to a kit for testing the integrity of sterile tubing welds made by a sterile tubing welding apparatus.
U.S. Pat. No. 4,610,670 provides a sterile tubing welding machine for sterilely connecting sterile, closed end tubes. The process used in conjunction with the welding machine comprises flattening a section of each tube to urge inside walls of each tube into contact, urging a hot cutting means through the flattened section of each tube thereby temporarily sealing together the inside walls of each tube and providing molten tube ends, aligning the tubes to be connected with each other, joining the desired molten ends of the tubes together to form a joint between the tubes, and cooling the joint and then subjecting it to stress to open the temporary seal in each tube, thereby providing fluid communication between the joint tubes.
The machine covered by the above-noted patent comprises a cutting means, means adapted to heat the cutting means, a pair of mounting blocks adapted to receive, hold and flatten the tubes to be joined, means to provide movement between the blocks and the cutting means to a position such that the cutting means is between the blocks and traversing where the blocks are adapted to hold tubes, means for realigning the blocks to a position where two different tube ends are aligned with and facing each other, means to separate the blocks and the cutting means, and means for urging the mounting blocks together. The tubes to be connected according to this process have closed ends, i.e., the tubes have sealed ends, a tube is connected to a container such as a blood bag or dialysis bag, the tube is connected to a catheter implanted in a patient, or in some other manner the tube ends are closed to the external environment. Other patents which present similar aspects of this machine are disclosed in U.S. Pat. Nos. 4,369,779, 4,461,951, 4,476,631, and 4,501,951.
In the course of using the aforementioned sterile tubing welding machine, customers have requested that the manufacturer provide documentation that satisfies certified good manufacturing practices and quality assurance requirements relating to manufacturing protocols applicable to the welding machine. To provide customers with statistical documentation that their welding machine is operating within the manufacturer's strength specifications and to provide verification that the customer is utilizing the welding machine properly, it would be beneficial to provide a method of verifying the quality of welds made with the welding machine in the form of a convenient feedback system or kit.
What is needed in the art is a comprehensive survey arrangement by which the manufacturer may easily track the working progress of each welding machine so that individual customers can be informed of the quality and strength of welds made by their machines. It is thus desirable to provide a process which can provide for early detection of a possible potential machine failure. It is also necessary to provide a system which affords the manufacturer the opportunity to provide corrective action to improve the welding product according to the specified application identified by the customer. On a broader basis, it would be desirable to create a program which improves the communication between the manufacturer and the customer of the sterile tubing weld machine.